European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank (chILD-EU)
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|ClinicalTrials.gov Identifier: NCT02852928|
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : October 3, 2017
|Condition or disease|
|Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis Pulmonary Eosinophilia Pulmonary Fibrosis Respiratory Distress Syndrome, Newborn Child|
Objective 1: Generation of a common European database and biobank. The existing national programmes to collect data on chILD in three countries (France, Germany, UK) will enable the consortium to swiftly adapt current frameworks to a functionally appropriate pan-European web-based database and biobank. Importantly, compatibility with ongoing United States chILD data base developments will be factored in.
Objective 2: Continuous assessment and implementation of guidelines and treatment protocols. Our Standards Working Group will convene regularly. Initial tasks will establish (a) specific diagnostic pathways, including detailed protocols for gathering clinical information, blood testing, imaging and pathology ("Best Practice Checklist"); (b) international panels of clinicians, geneticists, radiologists and pathologists who will review every diagnosis to quality control the data; and (c) detailed protocols for follow up to generate natural history data.
Objective 3: Recruitment of a carefully characterized cohort of chILD patients. European wide recruitment and interdisciplinary critical peer review of all diagnoses submitted from across Europe is imperative. Each case will be given a diagnosis independently; if no firm diagnosis is possible, we will review the case periodically as new information becomes available. During the first year of the study, clinicians´ decisions according to local practice and outcomes will be independently monitored and assessed.
Objective 4: Determine the value of outcomes used in chILD. We will systematically optimize and clarify the relative weight of a large spectrum of single and composite clinical outcomes (using both clinician and carer scoring), sequential limited chest CT (to minimise radiation exposure), lung function testing, histopathological categorization of lung biopsies, serum markers and genetic tests. Variability, reproducibility and the effects of training on reading images will be investigated.
Objective 5: Assess treatment variations used, deliver data from defined protocols and linked outcomes. This project will analyse in detail treatment and outcomes within and between subjects using data collected. Analysis of the collected data will enable us to support the definition of trial protocols planned in the future.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Orphans Unite: chILD Better Together - European Management Platform for Childhood Interstitial Lung Diseases / chILD-EU - International Register and Biobank for Children´s Interstital Lung Disease|
|Actual Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
- Included subjects with specific diagnosis [ Time Frame: 10 years ]
- Survial [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852928
|Contact: Matthias Griese, Prof.||+49/89/440057871||Matthias.Griese@med.uni-muenchen.de|
|Contact: Meike Hengst, Dr. med.||+49/89/440057878||Meike.Hengst@med.uni-muenchen.de|
|Université Pierre et Marie Curie||Not yet recruiting|
|Paris, France, 75571|
|Contact: Annick Clement, Prof +33-1 44 73 66 68 firstname.lastname@example.org|
|Medizinische Hochschule Hannover||Recruiting|
|Hannover, Niedersachsen, Germany, 30625|
|Contact: Nicolaus Schwerk, MD +49 (0) 511 5329 ext 138 email@example.com|
|Contact: Martin Wetzke, MD +49 (0) 511 5329 ext 138|
|University of Padova||Recruiting|
|Padova, Italy, 35128|
|Contact: Deborah Snijders, Dr +39 049 821 8015 firstname.lastname@example.org|
|Hacettepe University, Medical Faculty||Recruiting|
|Ankara, Sihhiye, Turkey, 06100|
|Contact: Nural Kiper, Prof +903123051224 email@example.com|
|Contact: Nagehan Emiralioglu, Dr. +903123051334 firstname.lastname@example.org|
|University of Edinburgh||Recruiting|
|Edinburgh, United Kingdom, EH4 2XU|
|Contact: Steve Cuningham, Dr. +441315360640 email@example.com|
|Contact: Morag MaClean +44131 537 3846 / 3878 chILD-UK@ed.ac.uk|
|Study Chair:||Matthias Griese, Prof.||Klinikum der Universität München, Dr. von Haunersches Kinderspital|
|Principal Investigator:||Steve Cunningham, Dr.||University of Edinburgh|